Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Of 1057 HIV-infected participants, 174 participants were not randomized to receive study drug, the main reason being that they did not meet the study criteria (133/174; 76%). 441 randomized to ATV received any drug and 437 randomized to LPV received any drug. 438 and 440 participants randomized to ATV and LPV, respectively, received correct drug.

Reporting Groups

Description

ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD

Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.

LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD

Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.

LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48

Measure Description

MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.

Time Frame

Baseline (Day 1) and Week 48

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants analyzed are as-treated participants with evaluable baseline MOS-HIV. The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups

Description

ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD

Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.

LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values

ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD

LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Participants Analyzed [Units: Participants]

347

351

Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 [Units: Units on Scale]Mean (Standard Error)

Physical Health Summary (296, 287)

3.8 (0.50)

3.3 (0.49)

Mental Health Summary (296, 287)

6.0 (0.54)

5.6 (0.54)

Overall Health Perception Subscale (305, 297)

15.6 (1.53)

13.7 (1.51)

Physical Function Subscale (303, 298)

5.8 (1.28)

5.3 (1.24)

Role Function Subscale (307, 298)

8.5 (1.75)

8.1 (1.75)

Social Function Subscale (308, 295)

9.2 (1.48)

7.4 (1.66)

Cognitive Function Subscale (307, 300)

4.8 (1.25)

5.6 (1.05)

Pain Subscale (308, 297)

8.3 (1.39)

8.0 (1.39)

Mental Health Subscale (306, 300)

8.3 (1.21)

8.7 (1.10)

Energy/Fatigue Subscale (304, 300)

8.4 (1.25)

7.9 (1.21)

Health Distress Subscale (304, 300)

14.3 (1.39)

15.0 (1.36)

Quality of Life Subscale (308, 300)

12.9 (1.39)

8.4 (1.34)

Health Transition Subscale (308, 300)

11.0 (1.63)

8.8 (1.64)

No statistical analysis provided for Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48

51. Secondary:

Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) [ Time Frame: IBS-QoL is administered at baseline (Day 1) and Week 4. ]

Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL) [ Time Frame: Baseline (Day 1) and Week 24 ]

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 [ Time Frame: From Day 1 through Week 96 ]

Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48 [ Time Frame: DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48. ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.